Commentaries on Wagener et al. (2012):
LET'S KEEP OUR ‘EYE ON THE BALL’: REDUCING TOBACCO-RELATED HARM
Version of Record online: 2 AUG 2012
© 2012 The Authors, Addiction © 2012 Society for the Study of Addiction
Volume 107, Issue 9, pages 1554–1555, September 2012
How to Cite
WAGENER, T. L., SIEGEL, M. and BORRELLI, B. (2012), LET'S KEEP OUR ‘EYE ON THE BALL’: REDUCING TOBACCO-RELATED HARM. Addiction, 107: 1554–1555. doi: 10.1111/j.1360-0443.2012.04012.x
- Issue online: 2 AUG 2012
- Version of Record online: 2 AUG 2012
- Electronic cigarettes;
- harm reduction;
We are very pleased that our recent For Debate article  stirred interest and thoughtful discussion related to the topic of electronic cigarettes (e-cigarettes). The commentaries provided by Drs Hajek , Bauld  and Etter  generally agree that e-cigarettes are promising, that there is a need for more research and that there is not enough scientific evidence to discourage their use at this time. All three commentaries also extended our original points: Dr Hajek examined the potential benefit of e-cigarettes as a consumer nicotine product that directly competes with conventional tobacco cigarettes and called for the public health community to support their development; Dr Bauld discussed the UK's Medicines Healthcare Regulatory Agency decision to respond to the differing views of the public health community and current e-cigarette users by coordinating a period of further research on the impact of potential e-cigarette regulation on public health; and Dr Etter discussed that healthcare providers should inform smokers interested in e-cigarettes that research is scarce but that compared to regular cigarettes the health risks appear to be lower, and that current e-cigarette users should not be deterred by healthcare providers from continued use if they are finding that it is helping them quit smoking.
We believe that our thesis was misconstrued by Cobb & Abrams . The main goal of our article was a call for a more balanced perspective regarding the potential utility of e-cigarettes by researchers, tobacco control experts and the FDA. The current FDA website , for example, does not cite any of the potential promise of e-cigarettes and overstates some of the data on risk. We concluded our initial commentary by stating that the ‘initial evidence suggests that e-cigarettes offer more promise than peril’ and we called for future discussion to be ‘based on a balanced view of the available science rather than an ideology that opposes harm reduction’. At no point in the article did we call for ‘turning back the clock’ on the FDA and public health or an e-cigarette market ‘unfettered by national regulatory agencies’.
We are strongly in favor of FDA regulation of e-cigarettes under the Family Smoking Prevention and Tobacco Control Act (FSPTCA) through the Center for Tobacco Products (CTP). We are in agreement with Cobb and Abrams' call for the FDA to regulate e-cigarettes. We believe that the FDA should act quickly to exercise their regulatory authority over these products. Our academic debate should continue but should not, as Cobb & Abrams contend ‘foster delay in regulations’. The FDA has already been granted regulatory authority over tobacco products. We understand that Cobb & Abrams would prefer that e-cigarettes not be regulated as tobacco products but instead as drug delivery devices under the regulatory authority of the U.S. FDA's Center for Drug Evaluation and Research (CDER). However, this idea falls foul of the D.C. District Court decision  which prohibited the FDA from regulating e-cigarettes under the Food, Drug, and Cosmetics Act in the absence of therapeutic claims. Thus, the only option that the FDA has is to regulate e-cigarettes as tobacco products under the FSPTCA. However, if in the future, e-cigarette companies, tobacco companies, or refined nicotine companies want to put a health claim on their product or market it as ‘modified risk’, then they too should be required to demonstrate the necessary safety and efficacy standards to obtain the designation as a pharmaceutical product or modified risk tobacco product, through CDER or CTP, respectively.
What we were disputing was Cobb & Abrams presentation of the scientific information regarding the potential effectiveness of these products, concerns over repeated propylene glycol inhalation, and risks of potential child or adult overdose of nicotine liquid or ‘e-juice’—selecting pieces of information from studies that supported their hypotheses while ignoring information that did not.
Cobb & Abrams report difficulty reconciling ‘continued strict regulation of pharmaceutical nicotine and its competing delivery systems, with the unregulated sale of nicotine in “electronic” form’. To us, it is more perplexing trying to reconcile why should the e-cigarette, a product that delivers nicotine without the harmful effects of combustion, be banned from the market until it can be proven safe and effective, while the tobacco cigarette, a product we know to be harmful and deadly, is allowed to stay? We continue to call for a balanced perspective on e-cigarettes and still find that the current evidence suggest that they offer more promise than peril. We agree with Drs Bauld, Etter and Hajek that e-cigarettes are likely to be safer than tobacco cigarettes but that more research is needed. We hope that the public health community will keep their ‘eye on the ball’ and embrace new approaches to harm reduction and smoking cessation.
- 6U.S. Food and Drug Administration (FDA). Electronic Cigarettes. 2011. Available at: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm (accessed 12 July 2012; archived by Webcite at http://www.webcitation.org/696C6WqSL).
- 7United States District Court For the District of Columbia: 2010 Civil Case No. 09-771. Memorandum Opinion by Richard J. Leon. Available at: https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54 (accessed 12 July 2012; archived by Webcite at http://www.webcitation.org/696CDFCv2).